Observational Prospective Study to Evaluate AEs, Risk Factors and Drug Utilization of BUSCAPINA COMPOSITUM N in Adults From Metropolitan Lima

Observational Prospective Cohort Study to Evaluate the Incidence of Adverse Events (AE), Risk Factors, and Drug Utilization Patterns Related to Treatment With BUSCAPINA COMPOSITUM N From March to December 2016 in Patients From Metropolitan Lima

What AE occur in routine clinical practice, what is the incidence of AE and Adverse Drug Reaction, how many patients present with AE symptoms related to a potential liver injury. What are the drug utilization patterns in patients, what are the predisposing factors for the occurrence of adverse events and adverse drug reactions.

Study Overview

• Status: Completed
• Conditions: Acute Pain; Dysmenorrhea
• Intervention / Treatment: Drug: Paracetamol; Drug: Hyoscine n-butylbromide

• Study Type: Observational
• Enrollment (Actual): 360

Contacts and Locations

Study Locations

• Peru
  • Multiple Locations, Peru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Metropolitan Lima

Description

Inclusion criteria:

1. Patients 18 years of age and older who have received at least one dose of BUSCAPINA COMPOSITUM N according to label indications and who attend to one of the pharmacies, clinics, or private doctors office selected for the study.
2. Patients who agree to adhere to the protocol procedures of this study.
3. Women who are not pregnant or breast feeding
4. Persons who sign the informed consent

Exclusion criteria:

1. Patients with allergy to BUSCAPINA COMPOSITUM N or any of the compounds in the formula.
2. Patients with mechanical stenosis of the gastrointestinal tract.
3. Patients with myasthenia gravis.
4. Patients with megacolon.
5. Patients breastfeeding at the time of enrollment or who have become pregnant during treatment with BUSCAPINA COMPOSITUM N.
6. Patients with clinical evidence of immunosuppression.
7. Patients with urinary retention subvesical obstruction (such as prostatic adenoma).
8. Patients with right-angle glaucoma.
9. Patients with tachycardia and tachyarrhythmia.
10. Patients with severe hepatic impairment.
11. Patients with psychiatric disorders.
12. Patients with alcohol dependence or drugs.
13. Patients who discontinue the protocol are not eligible for re-enrollment.
14. Researchers, company personnel or their relatives.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Men with spasmodic syndromes; Men with any type of gastrointestinal, hepato-biliary, urinary or genital spasmodic syndromes	Drug: Paracetamol; Paracetamol 500 mg; Drug: Hyoscine n-butylbromide; Hyoscine n-butylbromide 10 mg
Women with spasmodic syndromes; Women with any type of gastrointestinal, hepato-biliary, urinary or genital spasmodic syndromes	Drug: Paracetamol; Paracetamol 500 mg; Drug: Hyoscine n-butylbromide; Hyoscine n-butylbromide 10 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients With an Incidence of Adverse Event (AE) Associated to Potential Liver Damage During the Clinical Evaluation of Patients	Percentage of patients with an incidence of Adverse Event (AE) associated to potential liver damage during the clinical evaluation of patients.	From the initial dose of study drug until end of the follow up period, up to 113 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients With Different Transaminase Levels Found by the Doctor During the Clinical Evaluation of Patients With Symptoms Related to Potential Liver Damage.	Percentage of patients with different transaminase levels found by the doctor during the clinical evaluation of patients with symptoms related to potential liver damage. No patient with symptoms related to potential liver damage was identified, thus analyses of transaminase levels was not performed.	From the initial dose of study drug until end of the follow up period, up to 113 days
Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima	Percentage of patients with different drug utilization patterns of Buscapina Compositum N in patients in Metropolitan Lima.	From the initial dose of study drug until end of the follow up period, up to 113 days
Percentage of Patients Per Adverse Event Preferred Term in Patients Who Developed Any Adverse Event During Treatment	Percentage of patients per adverse event preferred term in patients who developed any adverse event during treatment with Buscapina Compositum N.	From the initial dose of study drug until end of the follow up period, up to 113 days
Percentage of Patients With Different Variables Related to the Occurrence of Increase of Transaminases in Patients Under Treatment With Buscapina Compositum N	Percentage of patients with different variables related to the occurrence of increase of transaminases in patients under treatment with Buscapina Compositum N in Metropolitan Lima. No patient with symptoms related to potential liver damage was identified, thus analyses of transaminase levels was not performed.	From the initial dose of study drug until end of the follow up period, up to 113 days

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2016
• Primary Completion (Actual): February 20, 2017
• Study Completion (Actual): February 20, 2017

Study Registration Dates

• First Submitted: August 30, 2016
• First Submitted That Met QC Criteria: September 19, 2016
• First Posted (Estimate): September 21, 2016

Study Record Updates

• Last Update Posted (Actual): March 27, 2019
• Last Update Submitted That Met QC Criteria: March 26, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Pelvic Pain; Acute Pain; Dysmenorrhea; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Antiemetics; Gastrointestinal Agents; Adjuvants, Anesthesia; Mydriatics; Acetaminophen; Scopolamine; Butylscopolammonium Bromide
• Other Study ID Numbers: 218.705